Paget Disease of Bone
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-02-22FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ibandronate sodium filed by Aurobindo Pharma Limited, approving the generic product under the AN…
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FDA approval · 2021-11-10FDA Approved: CALCITONIN SALMON — Original Application (Par Health USA, LLC)
The FDA approved Par Health USA's generic Calcitonin Salmon under ANDA 209358.
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FDA approval · 2021-05-14FDA Approved: CALCITONIN SALMON — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s original application for a generic Calcitonin Salmon product (ANDA 212416).
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FDA approval · 2020-10-20FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Zoledronic acid from Hikma Pharmaceuticals USA Inc., indicating regulatory approval for the spon…
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FDA approval · 2020-10-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for zoledronic acid from Mylan Institutional LLC under an abbreviated new drug application (ANDA), e…
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FDA approval · 2020-08-26FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for Calcitonin Salmon (Endo USA, Inc.), resulting in updated labeling for the product.
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FDA approval · 2020-08-06FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Risendronate Sodium from Aurobindo Pharma Limited.
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FDA approval · 2020-06-08FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
FDA approves a supplemental application for BINOSTO (alendronate sodium) submitted by Radius Health, Inc.
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FDA approval · 2020-04-29FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.
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FDA approval · 2020-02-21FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for Zoledronic acid from Dr. Reddy's Laboratories Limited, authorizing a generic product through…
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FDA approval · 2019-08-19FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2019-07-09FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industires Inc.)
FDA approved Sun Pharmaceutical's risendronate sodium as an original application for a generic product, with indications for osteoporosis-re…
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FDA approval · 2019-02-15FDA Approved: RISEDRONATE SODIUM — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd)
FDA approved the generic drug risedronate sodium under an Original Application, expanding access to this bisphosphonate for osteoporosis- an…
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FDA approval · 2018-06-29FDA Approved: ZOLEDRONIC ACID — Original Application (Gland Pharma Limited)
The FDA approved an Original Application for a generic zoledronic acid product by Gland Pharma Limited.
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FDA approval · 2017-07-07FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc.
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FDA approval · 2017-04-18FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)
FDA approved a supplemental application for alendronate sodium tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB) [Phase 4]
This Phase 4 trial evaluates the efficacy and safety of a single 5 mg dose of zoledronic acid in Chinese patients with Paget's Disease of Bo…
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FDA approval · 2016-11-29FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's original ANDA for a generic rise-dronate sodium product (RISEDRONATE SODIUM). The approved i…
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FDA approval · 2016-10-21FDA Approved: RISEDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original ANDA for risedronate sodium, a generic osteoporosis treatment, enabling market entry.
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FDA approval · 2016-07-14FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a supplemental application for a generic zoledronic acid product from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals)…
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FDA approval · 2016-05-24FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc. The approval updates the product's labeli…
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FDA approval · 2016-04-08FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium filed by Aurobindo Pharma Limited (ANDA 090124).
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CLINICAL_TRIALS trial_result · 2016-03-31Clinical Trial Update: Bisphosphonate Therapy for Osteogenesis Imperfecta [Phase 4]
Phase 4 clinical trial update evaluating bisphosphonate therapy for osteogenesis imperfecta; the study is completed and results were posted …
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FDA approval · 2016-03-29FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC. This action indicates regula…
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FDA approval · 2016-03-25FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for zoledronic acid filed by Sagent Pharmaceuticals.